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news.The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have granted paediatric clinical trial waivers to Shanton Pharma for its lead candidate SAP-001, easing the drug’s regulatory paths to approval.
The European determination follows an agreed initial PSP submitted in May of this year to the US FDA. Credit: Stock-Asso/Shutterstock.com.
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Under an agreement reached with the EMA on a paediatric investigation plan (PIP), the clinical-stage biotechnology company received a full, product-specific waiver.
The decision applies across all paediatric age groups diagnosed with hyperuricemia, except for conditions arising from obesity or chronic kidney disease.
The European determination follows an agreed initial paediatric study plan (PSP) submitted in May of this year to the FDA.
Regulators at the FDA similarly exempted SAP-001 from paediatric study requirements because gout occurs with extremely low frequency in children.
Shanton Pharma CEO Bing Li said: “We are pleased that the EMA and FDA have determined that paediatric clinical studies evaluating SAP-001 are not needed to support market authorisation applications for hyperuricemia and gout.
“The EMA and FDA waivers significantly lessen the administrative and regulatory burden and lower the overall cost of clinical development of SAP-001.”
SAP-001 is an investigational, once-daily oral urate-lowering therapy designed to treat uncontrolled and refractory gout in adult patients.
In a recent Phase IIb study (NCT05690204), the compound demonstrated efficacy and safety in individuals whose hyperuricemia failed to respond to standard-of-care xanthine oxidase inhibitor treatments.
Last year, the FDA granted fast track designation (FTD) to the drug candidate, supported in part by the Phase IIb results indicating its potential to improve upon existing urate-lowering therapies for patients facing unmet medical needs.
Established in 2016 by pharmaceutical entrepreneurs, Shanton Pharma is a privately held business focused on developing treatments for adults with gout and hyperuricemia.
The company maintains its corporate headquarters in Singapore, alongside research and development activities based in China, Singapore, and the US.
